On December 21, 2015 OPKO Health, Inc. (NYSE: OPK) through its subsidiary GeneDx, reported results from the largest published study to date of patients who received hereditary genetic testing with Next Generation Sequencing (NGS) cancer panels (Press release, Opko Health, DEC 21, 2015, View Source [SID:1234508623]). The study, "Pathogenic and Likely Pathogenic Variant Prevalence among the First 10,000 Patients Referred for Next Generation Cancer Panel Testing," was published in the December 2015 issue of Genetics in Medicine. GeneDx’s analysis of the data generated from the first 10,030 patients highlights the clinical utility of testing for multiple cancer genes to identify variants that would not have been identified through previously used testing methods. The patients, who were referred for testing between August, 2013 and October, 2014, underwent genetic testing for panels of genes associated with hereditary cancer.

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While many patients were found to carry pathogenic or likely pathogenic variants in well-established, high-risk cancer genes, approximately half of the pathogenic variants identified were in genes with moderate risk and in recently identified cancer genes. Notably, among women with breast cancer, 50% of positive findings were in genes other than BRCA1 or BRCA2. Additionally, several individuals had pathogenic variants in high-risk genes that were somewhat unexpected, so clinical presentation alone might not have prompted testing for these genes.

"We believe that molecular diagnostic testing for panels containing multiple genes are significantly more accurate in determine the heritable factors which increase the risk of cancer, and may permit more tailored treatment for cancer patients and screening for their family members," said Sherri Bale, PhD, FACMG, Co-Founder and Managing Director of GeneDx. "Our experience, based on a large database of patients, demonstrates that multi-gene panels have the potential to identify pathogenic variants in genes that would not typically have been tested and most likely would have been missed. This study provides important empirical data for clinical decision-making when choosing between single genes and NGS cancer panel testing for a variety of cancers."

On December 21, 2015 Foundation Medicine, Inc. (NASDAQ:FMI) reported that it has signed a national agreement for FoundationOne, a comprehensive genomic profiling assay for solid tumors, with UnitedHealthcare, one of the nation’s largest private payers (Press release, Foundation Medicine, DEC 21, 2015, View Source [SID:1234508618]). The Agreement, which became effective December 15, 2015, covers FoundationOne for patients with metastatic stage IV non-small cell lung cancer (NSCLC). In the United States, approximately 50 percent of patients with NSCLC have metastatic disease at the time of diagnosis.1

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FoundationOne is a comprehensive genomic profile that enables physicians to make treatment decisions for patients with cancer by identifying the molecular growth drivers of their cancers and by helping oncologists match the identified drivers with relevant targeted therapeutic options. Requiring only a small amount of tumor tissue, FoundationOne interrogates the entire coding sequence of 315 cancer-related genes plus select introns from 28 genes that are known to be altered in solid tumors.

"UnitedHealthcare’s coverage decision is a critical first step towards ensuring that comprehensive genomic profiling becomes standard-of-care treatment for patients with metastatic disease," said Bonnie J. Addario, lung cancer survivor, and founder of the Bonnie J. Addario Lung Cancer Foundation and the Addario Lung Cancer Medical Institute. "Lack of reimbursement for comprehensive genomic profiling tests, like FoundationOne, continues to be one of the major barriers impeding patient access to potentially life-extending therapies for which the patient is a molecular match."

"This national coverage agreement with UnitedHealthcare is an important step towards broader reimbursement for Foundation Medicine, and importantly, it’s a significant advance for patients with metastatic NSCLC," said Michael Pellini, M.D., chief executive officer for Foundation Medicine. "Studies demonstrate that improved clinical outcomes are achieved by matching patients to targeted therapies based on the unique genomic alterations contributing to the disease. We look forward to building upon our relationship with UnitedHealthcare and other national insurers as we continue to demonstrate clinical and economic evidence supporting coverage and payment for FoundationOne in additional cancer types."

On December 21, 2015 Array BioPharma Inc. (NASDAQ: ARRY) reported the closing of its definitive agreement with Pierre Fabre following approval of the agreement by the European Commission on Competition (ECC) (Filing, 8-K, Array BioPharma, DEC 21, 2015, View Source [SID:1234508616]). The definitive agreement, announced on November 16, 2015, relates to globally developing and commercializing Array’s late-stage novel oncology products, binimetinib and encorafenib. Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, are currently advancing in three, global Phase 3 trials for melanoma and ovarian cancer.

About the Array / Pierre Fabre Agreement
Under the terms of the agreement, Array will receive an upfront payment of $30 million and retains exclusive commercialization rights for binimetinib and encorafenib in the United States, Canada, Japan, Korea and Israel. Pierre Fabre will have exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. Array is entitled to receive up to $425 million if certain development and commercialization milestones are achieved, and is eligible for robust, tiered double-digit royalties. Array and Pierre Fabre have agreed to split future development costs on a 60:40 basis (Array:Pierre Fabre) with initial funding committed for new clinical trials in colorectal cancer and melanoma. All ongoing binimetinib and encorafenib clinical trials remain substantially funded through completion by Novartis.

About Binimetinib and Encorafenib
RAF and MEK are key protein kinases in the RAS/RAF/MEK/ERK pathway. Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal, ovarian and thyroid cancers. Binimetinib is a small molecule MEK inhibitor and encorafenib is a small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Three Phase 3 trials in advanced cancer patients continue to advance: NRAS-mutant melanoma (NEMO, with binimetinib), low-grade serous ovarian cancer (MILO, with binimetinib) and BRAF-mutant melanoma (COLUMBUS, with binimetinib and encorafenib). Array announced on December 16, 2015 that NEMO met its primary endpoint of improving progression-free survival compared with dacarbazine treatment. Array plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. Array also projects a regulatory filing of binimetinib in combination with encorafenib in BRAF melanoma in 2016.

About Pierre Fabre and Pierre Fabre Oncology
Pierre Fabre is a French privately-owned health and beauty care company created in 1961 by Mr. Pierre Fabre. In 2014, global sales reached €2.1 billion across 130 countries. The company is structured around two divisions: Pharmaceuticals (Prescription drugs, Consumer Health Care) and Dermo-cosmetics (including the European and Asian market-leader Eau Thermale Avene brand). Pierre Fabre employs some 10,000 people worldwide and owns subsidiary in 43 countries. In 2014, the company allocated 17 percent of its pharmaceuticals sales to R&D with a focus on 4 therapeutic areas: oncology, dermatology, CNS and consumer health care.
Pierre Fabre Oncology, a business unit of the Pierre Fabre company, is supported by over 1,000 employees with a strong focus on European markets. In 2014, worldwide annual sales of Pierre Fabre Oncology products surpassed $200 million on the strength of the Oral Navelbine, Javlor and Busilvex brands. In addition, Pierre Fabre has a significant commitment and track record in pharmaceutical R&D, developing products for patients afflicted with lung, breast and other solid tumors and hematological cancers.

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